Head of Biologic Drug Substance - Process & Analytical Development (Biotech)

TL;DR

Head of Biologic Drug Substance - Process & Analytical Development (Biologics): Defining and executing strategy for biologics CMC development—including process development, analytical sciences, and regulatory readiness—from early-stage research through commercial launch. Focus on designing scalable manufacturing processes, leading technology transfer and scale-up, and ensuring compliance with global regulations.

Location: Preferred locations are Italy and Sweden, with possibility of smart working. Willingness to travel domestically and internationally as needed.

Company

International research-focused biopharmaceutical group with 90 years’ experience, headquartered in Parma, Italy, operating in more than 30 countries.

What you will do

• Lead Drug Substance Process & Analytical Development activities, setting strategy for high-value biologic programs from early to late stage.
• Design, develop, and optimize robust, scalable biopharmaceutical manufacturing processes.
• Partner cross-functionally with Clinical, QA, Regulatory, Operations, and Preclinical teams for seamless program execution and technology transfer.
• Manage CDMO partnerships, evaluate manufacturing partners, and drive end-to-end development strategies.
• Champion innovation, introduce new technologies, and promote continuous improvement in biologics development.
• Lead CMC contributions for regulatory submissions and interactions with health authorities.

Requirements

• At least 10 years of experience in biopharmaceutical drug substance process development, with leadership in complex biologics CMC programs.
• Deep understanding of FDA, EMA, ICH, and global CMC guidelines.
• Significant experience managing CDMO partnerships and external development.
• Advanced scientific degree (Ph.D. or M.Sc.) preferred; Bachelor’s with relevant experience considered.
• Experience in technology transfer, scale-up, commercial readiness, and QbD principles.
• Proven leadership, communication skills, and ability to build high-performing teams.

Culture & Benefits

• Comprehensive healthcare programs, work-life balance initiatives, and robust relocation support.
• Competitive salary package with performance bonuses and market-benchmarked benefits.
• Flexible working arrangements, remote work options, and tax assistance for foreign colleagues.
• Access to resources and training for professional development.
• Commitment to diversity, inclusion, sustainability as a Benefit Corporation and B Corp.